Verastem initiates rolling submission of NDA to FDA for avutometinib and defactinib combo

Following the release of an American Society of Clinical Oncology (ASCO) abstract on Thursday, Verastem Oncology’s (Nasdaq: VSTM) shares were up 50% in aftermarket trading.

However, an update on the project’s filing plans brought the stock down to earth. The shares plummeted 66% to $4.12 by close of trading on Friday.

Verastem announced that it has initiated the rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking accelerated approval of the combination of avutometinib, a RAF/MEK clamp, and defactinib, a selective FAK inhibitor, for adult patients with recurrent KRAS mutant (KRAS mt) low-grade serous ovarian cancer (LGSOC), who received at least one prior systemic therapy.